WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants

833 Pages·2012·4.17 MB·English

Safety evaluation of
WHO FOOD
ADDITIVES certain food additives
SERIES: 65
and contaminants
Prepared by the
Seventy-fourth meeting of the Joint FAO/
WHO Expert Committee on Food Additives
(JECFA)
World Health Organization, Geneva, 2012
WHO Library Cataloguing-in-Publication Data
Safety evaluation of certain food additives and contaminants / prepared by the Seventy-fourth
meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(WHO food additives series ; 65)
1.Food additives - toxicity. 2.Food contamination. 3.Flavoring agents - analysis. 4.Flavoring
agents - toxicity. 5.Risk assessment. I.Joint FAO/WHO Expert Committee on Food
Additives. Meeting (74th : 2011 : Rome, Italy). II.World Health Organization. III.Series.
ISBN 978 92 4 166065 5 (NLM classification: WA 712)
ISSN 0300-0923
© World Health Organization 2012
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Typeset in India
Printed in Malta
CONTENTS
Preface ............................................................................................................................... v
Specific food additives
Aluminium-containing food additives (addendum) ........................................................ 3
Benzoe Tonkinensis ...................................................................................................... 87
Ponceau 4R (addendum) .............................................................................................101
Pullulanase from Bacillus deramificans expressed in Bacillus licheniformis ................117
Quinoline Yellow (addendum) .......................................................................................127
Sunset Yellow FCF (addendum) ...................................................................................141
Contaminants
Cyanogenic glycosides (addendum) ............................................................................171
Fumonisins (addendum) ...............................................................................................325
Annexes
Annex 1 Reports and other documents resulting from previous meetings of
the Joint FAO/WHO Expert Committee on Food Additives .........................797
Annex 2 Abbreviations used in the monographs .......................................................809
Annex 3 Participants in the seventy-fourth meeting of the Joint FAO/WHO
Expert Committee on Food Additives .........................................................813
Annex 4 Tolerable and acceptable intakes, other toxicological information
and information on specifications................................................................817

PREFACE
The monographs contained in this volume were prepared at the seventy-fourth
meeting of the Joint Food and Agriculture Organization of the United Nations (FAO)/
World Health Organization (WHO) Expert Committee on Food Additives (JECFA),
which met at FAO headquarters in Rome, Italy, on 14–23 June 2011. These
monographs summarize the data on selected food additives and contaminants
reviewed by the Committee.
The seventy-fourth report of JECFA has been published by the World Health
Organization as WHO Technical Report No. 966. Reports and other documents
resulting from previous meetings of JECFA are listed in Annex 1. The participants
in the meeting are listed in Annex 3 of the present publication.
JECFA serves as a scientific advisory body to FAO, WHO, their Member States
and the Codex Alimentarius Commission, primarily through the Codex Committee
on Food Additives, the Codex Committee on Contaminants in Food and the Codex
Committee on Residues of Veterinary Drugs in Foods, regarding the safety of
food additives, residues of veterinary drugs, naturally occurring toxicants and
contaminants in food. Committees accomplish this task by preparing reports of their
meetings and publishing specifications or residue monographs and toxicological
monographs, such as those contained in this volume, on substances that they have
considered.
The monographs contained in this volume are based on working papers that
were prepared by temporary advisers. A special acknowledgement is given at the
beginning of each monograph to those who prepared these working papers. The
monographs were edited by M. Sheffer, Ottawa, Canada.
The designations employed and the presentation of the material in this
publication do not imply the expression of any opinion whatsoever on the part of
the organizations participating in WHO concerning the legal status of any country,
territory, city or area or its authorities, or concerning the delimitation of its frontiers
or boundaries. The mention of specific companies or of certain manuf ac turers’
products does not imply that they are endorsed or recommended by the organi-
zations in preference to others of a similar nature that are not mentioned.
Any comments or new information on the biological or toxicological properties
of the compounds evaluated in this publication should be addressed to: Joint WHO
Secretary of the Joint FAO/WHO Expert Committee on Food Additives, Department
of Food Safety and Zoonoses, World Health Organization, 20 Avenue Appia, 1211
Geneva 27, Switzerland.
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SPECIFIC FOOD ADDITIVES

ALUMINIUM-CONTAINING FOOD ADDITIVES (addendum)
First draft prepared by
D.J. Benford,1 A. Agudo,2 C. Baskaran,1 M. DiNovi,3 D. Folmer,3
J.-C. Leblanc4 and A.G. Renwick5
1 Food Standards Agency, London, England
2 Catalan Institute of Oncology, L’Hospitalet de Llobregat, Spain
3 Center for Food Safety and Applied Nutrition, Food and Drug
Administration, College Park, Maryland, United States of America (USA)
4 Agence nationale de sécurité sanitaire de l’alimentation, de
l’environnement et du travail (ANSES), Maisons-Alfort, France
5 Emeritus Professor, University of Southampton, Southampton, England
1. Explanation ................................................................................. 4
2. Biological data ............................................................................. 6
2.1 Biochemical aspects ............................................................. 6
2.1.1 Absorption, distribution and excretion ......................... 6
(a) Absorption ............................................................. 6
(b) Distribution .............................................................. 11
(c) Excretion ................................................................. 12
2.1.2 Effects on enzymes and other parameters................... 12
2.2 Toxicological studies .............................................................. 13
2.2.1 Acute toxicity ................................................................ 13
2.2.2 Short-term studies of toxicity ........................................ 15
2.2.3 Long-term studies of toxicity and carcinogenicity ......... 16
2.2.4 Genotoxicity ................................................................. 17
2.2.5 Reproductive and developmental toxicity ..................... 17
(a) Multigeneration studies ........................................... 17
(b) Developmental toxicity ............................................ 23
2.2.6 Special studies ............................................................. 25
(a) Neurotoxicity and neurobehavioural studies ........... 25
2.3 Observations in humans ........................................................ 30
2.3.1 Biomarkers of exposure ............................................... 31
2.3.2 Biomarkers of effects .................................................... 31
2.3.3 Clinical observations .................................................... 31
(a) Case reports ........................................................... 31
(b) Aluminium in brain and Alzheimer disease ............. 32
2.3.4 Epidemiological studies ................................................ 32
(a) Aluminium in drinking-water and Alzheimer
disease, dementia and cognitive disorders ............. 33
(b) Dementia and aluminium in haemodialysis
patients ................................................................... 35
(c) Oral exposure to aluminium and bone health ......... 35
2.3.5 Occupational exposure to aluminium ........................... 37
3. Dietary exposure .......................................................................... 38
3.1 Introduction ............................................................................ 38
3.2 Use levels of the additives in food ......................................... 39
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